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Study Summary
No. 2005-0901:.......Advanced Cancers......Egidio Del Fabbro......Palliative Care & Rehabilitation Medicine
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Study Summary Title
Study Summary
Number:
2005-0901
Study Title:A randomized clinical trial of melatonin versus placebo and the effect on appetite in advanced cancer patients
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Physician New Patient Referral
Name:Egidio Del FabbroPatients Call:800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Dept:Palliative Care & Rehabilitation MedicineReferring MD
Call:
800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Phone:713-792-6085
Contact us about clinical trials
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General Information
Disease Group:Advanced CancersSupported By:N/A
Phase of Study:Phase IIIReturn
Visit:
Every two weeks for a period of 4 weeks for a total of two return visits.
Treatment
Agents:
MelatoninHome Care:N/A
Treatment Loc:Independent Multicenter Arrangements
Estimated
Length of Stay
in Houston:
N/A
Description/
Intervention:
The goal of this clinical research study is to evaluate the effectiveness of
melatonin for the management of poor appetite and weight loss in advanced
cancer patients. The effectiveness of melatonin on weight gain,
keeping/gaining of lean muscle mass, improved appetite, and side effects will
also be evaluated.
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Study Objectives / Outcomes
1) Primary objective: To determine if Melatonin will improve appetite in advanced cancer pts. with anorexia/cachexia as defined by an improvement of 1.5 in appetite score from baseline on the ESAS

2) Secondary objective-A: To determine if Melatonin will improve weight gain, and preserve/gain lean muscle mass in advanced cancer pts. with anorexia/cachexia

3) Secondary objective-B: To determine if Melatonin will improve pain, well-being, nausea, and depression as measured by the ESAS and FACIT-F in advanced cancer pts. with anorexia/cachexia
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Study Status Information
Study Activation / Registration Date:06/14/2006
IRB Review and Approval Date:01/18/2006
Study Type:Phase Iii
Recruitment Status:Open
Projected Accrual:126
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Enrollment Eligibility
If you do not meet the enrollment eligibility, there may be other treatment options for you. Please Contact the Referral Office for more information.

Inclusion Criteria:1) Patients with solid gastrointestinal tumors or lung cancer patients referred to palliative care and a 5% or more involuntary weight loss within the last 6 months with anorexia (>3 on visual analog scale such as ESAS)

2) Greater than or equal to 18 years of age

3) Karnofsky score of 40 or higher

4) Patient has the ability to maintain oral food intake during the study period

5) Patients who have persistent anorexia/cachexia and are currently taking a stable dose of Megace, corticosteroids, non-steroidal anti-inflammatories (NSAID'S), or thalidomide and started at least 2 weeks prior to study inclusion

6) Ability to sign informed consent and understand study procedures

7) Patient can continue all medications including complementary therapies or antineoplastic therapy while on-study other than melatonin if they have been on stable dose for at least 2 weeks

8) Negative pregnancy testing in women with child bearing potential defined as not post-menopausal for 12 months or no previous surgical sterilization.

9) Patients who cannot take Megace because of past history or elevated risk of DVT, adrenal insufficiency, impotence, hyperglycemia, CHF, menorrhgia, etc.

10) Patients who have persistent anorexia/cachexia after treatment with Megace has failed

Exclusion Criteria:1) Patients who have dementia or delirium on entry into study as determined by the palliative care specialist using DSM-IV-criteria

2) Patients who are currently taking melatonin

3) Inability to take oral food during the study period

4) Unstable secondary cachexia caused by nausea, diarrhea, taste abnormalities, mucositis, constipation, dysphagia, or clinical depression prior to study inclusion. These symptoms should be resolved or stable for >/= 2 weeks at the time of inclusion into study as determined by the Palliative Care Specialist.

5) Inability to sign informed consent or understand study procedures

6) Karnofsky score of < 40

7) Patients < 18 years of age

8) Patients with </= 5% involuntary weight loss within the last 6 months and anorexia of < 3 on ESAS

9) Patients who are on complementary therapies containing melatonin or on medications for < 2 weeks and not on stable dose

10) Patients who have a cortisol level of </= 4.3 mg/dL at baseline will be excluded.

11) Patients with a TSH of </= 0.50 or >/= 10 mcL/mL at baseline will be excluded

12) Pregnant females or females who are lactating/nursing

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Links
Registration Number: NCT00513357
Study Information on Clinical Trials Registry (clinicaltrials.gov)

Other Links:
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Results


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